ECSubmissionFormat object
Format option(s)
Online portal
Other
Online portal
(1) Portal ECM (Ensayos Clínicos con Medicamentos)
It also provides further guidance on the use of the portal and the application procedure.
(2) CD-ROM, e-mail or paper by attaching the specific documentation required by the EC. Online submission is compulsory for all ECs. Additionally, there are specific requirements for each EC the Sponsor has to fulfil.
Standard application form available
No
Standard application form
There is no standard application form for all RECs (each EC has its own specific forms).
Guidance on submission format
The application must include the documentation according to Art 16 of Circular 7/2004. A list of required documents (including practical examples) is available on the MSSSI website in section "Documentación del ensayo clínico para presentar a los CEIC"
